Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5261](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5261) → SAL — Device, Automated Cell Locating, Bone Marrow

# SAL · Device, Automated Cell Locating, Bone Marrow

_Hematology · 21 CFR 864.5261 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/SAL

## Overview

- **Product Code:** SAL
- **Device Name:** Device, Automated Cell Locating, Bone Marrow
- **Regulation:** [21 CFR 864.5261](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5261)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230034](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/SAL/DEN230034.md) | X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application | Scopio Labs , Ltd. | Mar 22, 2024 | DENG |

## Top Applicants

- Scopio Labs , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/SAL](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/SAL)

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